Recall Z-0618-2011 ยท HWC Screw, Fixation, Bone
Stryker Endoscopy
Stryker Titanium Intraline Anchor, Model Numbers 3910400050, 3910400055, 3910400060, 3910400065, Soft Eyelet Anchor, manufactured by Stryker Endoscopy, Puerto Rico
| Date | Dec 14, 2010 (initiated Aug 20, 2009) |
| Status | Terminated |
| Reason | Potential breakage -- product may break while inserting it into the bone during surgery. This may prolong surgery, or, if undetected during surgery, result in retained fragments that may cause metal sensitization or immune response, or necessitate further intervention to retrieve the titanium fragments. |
| Root cause | Material/Component Contamination |
| Action | Stryker issued an Urgent Device Removal notification letter dated August 21, 2009 to consignees. Consignees were asked to acknowledge receipt and distribute the letter, track reponses, and destroy any returned material and document through weekly summary and records. Stryker can be contacted at 408 754-2000 about this recall. |
| Quantity | 447 units |
| Distribution | Nationwide Distribution: to one distributor in NJ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071157 | STRYKER PEEK AND TITANIUM SOFT EYELET ANCHORS Stryker Endoscopy, Sep 17, 2007 |